Exploratory/Proof of Principle Microbiota Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mead Johnson Nutrition
- Enrollment
- 78
- Locations
- 1
- Primary Endpoint
- Fecal microbiota measured at each visit
Study Overview
Brief Summary
This clinical trial will evaluate the stool of infants fed one of two infant formulas, which contain different types of proteins, or breast milk to determine if different proteins have an effect on the type of bacteria that enters and lives in an infant's intestine early in life.
Detailed Description
This clinical trial will evaluate the stool of infants fed one of two infant formulas, which contain different types of proteins, or breast milk to determine if different proteins have an effect on the type of bacteria that enters and lives in an infant's intestine early in life.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 1 Day to 7 Days (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Singleton, 1-7 days of age at registration or randomization
- •Term infant with appropriate birth weight for gestational age
- •Either solely formula fed or exclusively receiving mother's own breast milk
- •Signed Informed Consent and Protected Health Information
Exclusion Criteria
- •Caesarean delivery
- •Infant was born from a mother with Type 1 diabetes
- •History of underlying metabolic or chronic disease or immunocompromised
- •Feeding difficulties or history of formula or human milk intolerance
- •Signs of acute infection of current use of antibiotics
Arms & Interventions
Extensively hydrolyzed casein infant formula
Intervention: Extensively hydrolyzed casein infant formula (Other)
Mother's own breast milk
Intervention: Mother's own breast milk (Other)
Amino acid based infant formula
Intervention: Amino acid based infant formula (Other)
Outcomes
Primary Outcomes
Fecal microbiota measured at each visit
Time Frame: 8 weeks
Sequencing and composition of samples
Secondary Outcomes
- Body weight measured at each visit(8 weeks)
- Parental recall of formula intake at each visit(8 weeks)
- Body length measured at each visit(8 weeks)
- Head circumference measured at each visit(8 weeks)
- Serious adverse events collected throughout the study period(8 weeks)
- Stool collection at each visit(8 weeks)